Actively Recruiting

Phase 3
Age: 18Years - 65Years
All Genders
NCT05527470

Induction Chemotherapy Followed by IMRT or Concurrent Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma

Led by Wei Jiang · Updated on 2023-05-03

440

Participants Needed

2

Research Sites

260 weeks

Total Duration

On this page

Sponsors

W

Wei Jiang

Lead Sponsor

W

Wuzhou Red Cross Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

In the era of comprehensive therapy, many studies have investigated the value of induction chemotherapy (IC) in the treatment of nasopharyngeal carcinoma (NPC). Concurrent cisplatin and radiotherapy is the foundation of concurrent chemoradiotherapy strategies, and the addition of cisplatin-based induction chemotherapy to concurrent chemoradiotherapy (CCRT) is considered to prolong survival by reducing distant metastasis in patients with high-risk disease. However, the severity of acute toxicities was significantly increased, which can compromise quality of life and lead to interruptions in CCRT. Fortunately, Locoregional control has substantially improved as the intensity-modulated radiation therapy (IMRT) technique has been widely used in the last decades, IMRT improved the treatment outcomes of patients with NPC, especially the local control rate. Currently, in the era of IMRT, whether patients with NPC benefit from IC plus radiotherapy alone and reduce toxicities compared with IC combined with CCRT. Therefore, the investigators propose this randomized phase III prospective study to assess the efficacy and contribution of IC plus radiotherapy alone in locoregionally advanced NPC during IMRT era.

CONDITIONS

Official Title

Induction Chemotherapy Followed by IMRT or Concurrent Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Newly diagnosed with non-keratinizing nasopharyngeal carcinoma confirmed by tissue analysis
  • Tumor stage III to IVb according to the 8th edition AJCC
  • Female participants who are not pregnant
  • Age between 18 and 65 years
  • Normal blood counts (hemoglobin >10 g/dL, white blood cells ≥4000/µL, platelets ≥100,000/µL)
  • Normal liver function (bilirubin ≤1.6 mg/dL, liver enzymes less than 2.5 times upper limit)
  • Normal kidney function (creatinine ≤1.5 mg/dL, creatinine clearance ≥60 mL/min)
  • ECOG performance status 0 or 1
  • No prior chemotherapy or radiotherapy
  • Signed informed consent provided
Not Eligible

You will not qualify if you...

  • Disease progressing during treatment
  • Uncontrolled life-threatening illness
  • Previous chemotherapy or radiotherapy
  • Pregnancy or breastfeeding

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Trial Site Locations

Total: 2 locations

1

Affiliated Hospital of Guilin Medical University

Guilin, Guangxi, China, 541001

Actively Recruiting

2

Wuzhou Red Cross Hospital

Wuzhou, Guangxi, China, 543002

Actively Recruiting

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Research Team

W

Wei Jiang, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Induction Chemotherapy Followed by IMRT or Concurrent Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma | DecenTrialz